DPM

GUDID 10841470111196

ENGINEERED MEDICAL SYSTEMS INC

Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered

• Primary Device ID: 10841470111196
• NIH Device Record Key: 1f9399f1-12e4-42b6-afc9-e14156ebef72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DPM
• Version Model Number: 301-5558
• Company DUNS: 154502934
• Company Name: ENGINEERED MEDICAL SYSTEMS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470111199 [Primary]
GS1	10841470111196 [Package]; Contains: 00841470111199; Package: [10 Units]; In Commercial Distribution
GS1	20841470111193 [Package]; Package: [120 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003497

FDA Product Code

• CAP: Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-20
• Device Publish Date: 2023-12-12

Devices Manufactured by ENGINEERED MEDICAL SYSTEMS INC

• 10841470108356 - FENEM: 2023-12-20
• 10841470108370 - FENEM: 2023-12-20
• 10841470109988 - A-PEP: 2023-12-20
• 10841470111196 - DPM: 2023-12-20
• 10841470111196 - DPM: 2023-12-20
• 10841470100220 - Bacterial/Viral Filter: 2023-12-19
• 00841470100230 - Pulmonary Function Filter: 2023-12-19
• 10841470100985 - Aero-Pro: 2023-12-19
• 10841470103436 - Aero-Pro: 2023-12-19